The effect of eight weeks water- based resistance exercise with dark chocolate consumption on serum follistatin level , quality of life and appetite in older adults
Semi-experimental experimentation with complete satisfaction of individuals, four intervention groups, simple accident, 38 people, blind and drug-free
Settings and conduct
Tehranpars Neighborhood Hall, 48 hours before and after the intervention of blood sampling and filling out the questionnaire by the participants, performed 8 weeks of intervention
Participants/Inclusion and exclusion criteria
Criteria for entering the study included healthy elderly people aged 60 to 73 years, sedentary lifestyle (not participating in regular sports activities in the last 12 months) and physical and mental health.
Criteria for leaving the study also include: history of specific diseases (such as chronic lung disease; ischemic heart disease; valvular heart disease; hypertrophic heart failure, etc.); Mental illness (such as dementia); muscle and joint injuries (such as lumbar disc herniation)
Intervention groups
Exercise, Exercise + Supplement, Supplement, Control
Main outcome variables
Independent variable: 8 weeks of practice in water; bitter chocolate
Dependent variable: Follistatin; Quality of life index; Appetite
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200609047708N1
Registration date:2020-07-12, 1399/04/22
Registration timing:retrospective
Last update:2020-07-12, 1399/04/22
Update count:0
Registration date
2020-07-12, 1399/04/22
Registrant information
Name
Masoumeh Mohamadkhani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7784 7528
Email address
mohamadkhni.m@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-17, 1398/07/25
Expected recruitment end date
2019-11-16, 1398/08/25
Actual recruitment start date
2019-10-17, 1398/07/25
Actual recruitment end date
2019-12-11, 1398/09/20
Trial completion date
2019-12-11, 1398/09/20
Scientific title
The effect of eight weeks water- based resistance exercise with dark chocolate consumption on serum follistatin level , quality of life and appetite in older adults
Public title
The effect of water resistance training and consumption of dark chocolate on the plasma level of follistatin, quality of life index and appetite of the elderly
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy elderly people between the ages of 60 and 73
sedentary (not participating in regular sports activities in the last 12 months)
physical health
mental health
Exclusion criteria:
History of specific diseases (such as chronic lung disease, ischemic heart disease, etc.
smoking
Mental illness (such as dementia)
Muscle and joint injuries (such as lumbar disc , etc.)
Age
From 60 years old to 73 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Actual sample size reached:
38
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Islamic Azad University Ethics Committee , Tehran Science and Research Branch
Street address
Hesarak Martyrs Boulevard, University Square,End of Shahid Sattari Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1477893855
Approval date
2019-10-16, 1398/07/24
Ethics committee reference number
IR.IAU.SRB.REC.1398.099
Health conditions studied
1
Description of health condition studied
The relationship between eight weeks of water resistance training and consumption of dark chocolate on the plasma level of follistatin, the quality of life index and appetite of the elderly
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
follistatin
Timepoint
Before the intervention, after eight weeks of intervention
Method of measurement
Blood sample by ELISA by special kit
2
Description
Life quality index
Timepoint
Before the intervention, after eight weeks of intervention
Method of measurement
SF-36 questionnaire
3
Description
appetite
Timepoint
Before the intervention, after eight weeks of intervention
Method of measurement
Questionnaire for mood swings
Secondary outcomes
1
Description
Water resistance training
Timepoint
Before the intervention, after eight weeks of intervention
Method of measurement
It is measured based on rating of percieved exertion (RPE)
Intervention groups
1
Description
Intervention group: 1 Exercise group: The subjects of this group performed water- based resistance exercise for eight weeks (3 sessions per week, each session for one hour).
Category
N/A
2
Description
Intervention group:2 exercises + supplements: The subjects of this group performed water - based resistance exercise in water for eight weeks with the consumption of dark chocolate (eight weeks water-based resistance exercises in water 3 sessions per week with daily consumption of 30 grams of dark chocolate and 6 bitter chocolate 5 g).
Category
N/A
3
Description
Intervention group:3 Supplementary groups: The subjects of this group consumed dark chocolate for eight weeks (daily consumption of 30 grams of dark chocolate, 6 bitter chocolate 5 grams).
Category
N/A
4
Description
Intervention group: 4 control groups: The subjects of this group did not have any additional training and consumption
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
District 8 Health Department, Tehranpars Neighborhood Hall, Elderly Center
Full name of responsible person
Masoumeh Mohamadkhani
Street address
West 108th Alley (Maleki), Dariush Station, Damavand St
City
Tehran
Province
Tehran
Postal code
1651967441
Phone
+98 21 7792 5052
Email
mohamadkhani.m96@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Masoumeh Mohamadkhani
Street address
Hesarak Martyrs Boulevard, University Square,End of Shahid Sattari Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1477893855
Phone
+98 21 4486 5179
Email
mohamadkhani.m96@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Masoumeh Mohamadkhani
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Masoumeh Mohamadkhani
Position
Student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Hesarak Martyrs Boulevard, University Square,End of Shahid Sattari Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1477893855
Phone
0098 21 44865179-82 /0098 21 44865154-8
Email
mohamadkhani.m96@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farshad GHazalian
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Hesarak Martyrs Boulevard, University Square,End of Shahid Sattari Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1477893855
Phone
0098 21 44865179-82 /0098 21 44865154-8
Email
phdghazalian@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Masoumeh Mohamadkhani
Position
Student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Hesarak Martyrs Boulevar, University Square, End of Shahid Sattari Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1477893855
Phone
0098 2144865179-82 /0098 2144865154-8
Email
mohamadkhani.m96@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available